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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007183
Receipt No. R000008462
Scientific Title Preoperative Biliary Drainage with Fully-Covered Self-Expandable Metallic Stents for Pancreas Head Cancer
Date of disclosure of the study information 2012/01/31
Last modified on 2013/08/06

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Basic information
Public title Preoperative Biliary Drainage with Fully-Covered Self-Expandable Metallic Stents for Pancreas Head Cancer
Acronym Preoperative Biliary Drainage with Fully-Covered Self-Expandable Metallic Stents for Pancreas Head Cancer
Scientific Title Preoperative Biliary Drainage with Fully-Covered Self-Expandable Metallic Stents for Pancreas Head Cancer
Scientific Title:Acronym Preoperative Biliary Drainage with Fully-Covered Self-Expandable Metallic Stents for Pancreas Head Cancer
Region
Japan

Condition
Condition Pancreas Head Cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the safety and efficacy of preoperative biliary drainage using a covered self-expandable metallic stent for pancreatic head cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes complication rate
Key secondary outcomes survival at the 90 days after the operation

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 placement of a covered self-expandable metallic stent
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who are strongly suspected of pancreatic head cancer based on the imaging examinations.
Patients who plesented obstructive jaundice(T-Bil is over 5.0mg/dL) or liver dysfunction(AST is more than 3 times the upper limit of normal).
Patients who are a candidate for surgery.
Written informed consent is obtained from patient before the study.
Key exclusion criteria Patients who are not able to stop the anti-coagulant therapy.
Patients who have severe heart disease, hepatic insufficiency, renal dysfunction, endocrine disease, or gastrointestinal tract disturbance.
Pregnant women. Women who have possibility of pregnancy.
Patients who are suspected of tumor involvement to the orifice of cystic duct.
Patients who are not suitable for endoscopic procedures.
Patients who already have received the endoscopic or percutaneously or surgically biliary drainage.
Patients who have symptoms of gastric outlet obstruction.
Patients who are judged inappropriate by chief (responsive) medical examiner
Target sample size 40

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Osamu Togawa
Organization Saitama International Medical Center
Division name Depertment of Gastroenterology
Zip code
Address 1397-1 Yamane, Hidaka, Saitama
TEL
Email

Public contact
1st name of contact person
1st name
Middle name
Last name Osamu Togawa
Organization Saitama International Medical Center
Division name Depertment of Gastroenterology
Zip code
Address 1397-1 Yamane, Hidaka, Saitama
TEL
Homepage URL
Email

Sponsor
Institute Saitama International Medical Center
Institute
Department

Funding Source
Organization nothing
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2010 Year 12 Month 24 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 01 Month 31 Day
Last modified on
2013 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008462

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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